MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	S-60-080-120-P6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.A conclusive cause for the reported hematoma, hypersensitivity/allergic reaction, pain and unspecified infection, and the relationship to the product, if any, cannot be determined.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The reported patient effect(s) of hematoma, hypersensitivity/allergic reaction, pain and infection is listed in the supera peripheral stent systems instructions for use as a potential adverse effect.
Event or Problem Description
It was reported that on (b)(6) 2024 the patient was dialyzed and had chronic limb threatening ischemia and there was occlusion and thrombosis below the knee noted by the physician.The 6x80 mm supera self expanding stent (ses) was implanted in the superficial femoral artery (sfa) to popliteal artery and a non-abbott stent was implanted in the mid sfa.The patient complained of pain the next day but was discharged home.The lesion appeared good one week after the procedure and tenderness is noted.About two weeks after implant, there was an inflammatory response noted in the lesion confirmed by computed tomography (ct).A hematoma is present, due to either allergic reaction, infection around the lesion or unconfirmed wire perforation.No additional treatment was provided.When treatment of the opposite foot is performed in the future, the physician plans to check for supera allergic reaction.No additional information was provided.

• Brand Name: SUPERA
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19967067
• Report Number: 2024168-2024-09491
• Device Sequence Number: 21063639
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: (01)08717648211812(17)241231(10)3010961
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: S-60-080-120-P6
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 3010961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELUVIA STENT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown